April 2, 2009 — Abbott yesterday announced the initiation of the MOBILITY clinical trial to study the safety and efficacy of the Absolute Pro Peripheral Self-Expanding Stent System in patients with iliac artery disease.
John Campbell, M.D., assistant professor of surgery and medicine, West Virginia University School of Medicine, Charleston Division, at the Charleston Area Medical Center in Charleston, W. Va., enrolled the first patient into the MOBILITY trial.
The MOBILITY trial will study 150 patients at up to 50 centers in the U.S. The primary endpoint is a composite measure of major adverse events (MAE) at nine months.
"Iliac artery occlusive disease has the potential not only to have a significant impact on a patient’s ability to carry on daily activities, but it also can be an early sign of plaque buildup in other parts of the body," said Manish Mehta, M.D., M.P.H., FACS, director of Endovascular Services, The Vascular Institute for Health and Disease, Albany Medical Center in Albany, N.Y., and co-principal investigator of the MOBILITY trial. "The lower extremity discomfort and fatigue with walking and exercise caused by this debilitating disease can tremendously impact a patient's overall quality of life, making it critical to find effective treatments. Data from the MOBILITY trial will be an important addition to iliac stenting research."
"As medical technology has advanced, iliac stenting has become an excellent first-line interventional treatment option for patients, as it is less invasive than surgery and has the potential to improve patient outcomes," said Tony S. Das, M.D., FACC, director, Peripheral Vascular Interventions, Cardiology Section, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY trial. "The MOBILITY trial will provide understanding into how the Absolute Pro peripheral stent treats the narrowing in the iliac artery to improve blood flow to the leg, with the ultimate goal of alleviating pain associated with PAD and improving the patient’s ability to walk and exercise."
The Absolute Pro peripheral stent is a self-expanding nitinol stent with a flexible and conformable design that is intended to keep lesions open without introducing more metal than necessary to treat a narrowing. The peripheral stent delivery system is compatible with 0.035'' (0.89 mm) guide wires.
The Absolute Pro Peripheral Self-Expanding Stent is currently an investigational device in the U.S. for the treatment of iliac artery disease.
For more information: www.abbott.com.